NCT06478563CompletedPhase 1
A Research Study Looking at Different Oral Formulations and the Effect of Food Intake on How the Medicine NNC0487-0111 Behaves in the Body of Participants Living With Overweight or Obesity
Investigating the Exposure of NNC0487-0111 in Different Oral Formulations and the Effect of Food Intake on Pharmacokinetics of NNC0487-0111 in Participants With Overweight or Obesity
Source: ClinicalTrials.gov · Last updated 11 Aug 2025
Brief summary (registry, in English)
This study consists of two phases: Phase A and Phase B. Participants are being asked to participate in both phases. Phase A of this study is comparing two formulations of a study medicine called NNC0487-0111 for weight control in people with overweight or obesity. Phase B of this study is testing how taking NNC0487-0111 at the same time as a meal affects the way NNC0487-0111 works in participants body. The aim of this study is to compare how two different formulations of NNC0487-0111 behave in the body, and how their function is affected when they are taken with or without a meal. Participants will either get NNC0487-0111 Formulation C, or NNC0487-0111 Formulation D. Both formulations are given as tablets. Which treatment participants get is decided by chance. Oral NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The study will last for about 5 - 6 months (155-184 days).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 133 (actual)
- First submitted
- 24 Jun 2024
- Start date
- 27 Jun 2024
- Primary completion date
- 5 Jun 2025
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Obesity
- NCT number
- NCT06478563
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 133
- From 27 Jun 2024 to the primary completion date, 5 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
Lab values
- Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
- Total calcium outside normal range at screening
- Glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole (mmol/mol)) at screening
Other
- Vitamin D (25-hydroxycholecalciferol) less than (\<) 12 ng/mL (30 Nanometer (nM)) at screening
- Parathyroid hormone (PTH) outside normal range at screening
- Calcitonin greater than or equal to (≥) 50 pg/mL at screening
- Amylase greater than or equal to (≥) 2 times upper limit of normal
- Lipase greater than or equal to (≥) 2 times upper limit of normal
Who the study is looking for
- Male or female
- Age 18-64 years (both inclusive)
- Body mass index (BMI) between 27.0 and 39.9 kilogram per meter square (kg/m\^2) (both inclusive)
- Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Celerion, Lincoln Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.